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pacemaker electrode perm temp
Daig
Summary: The pacemaker electrode perm temp by Daig is a cardiac device used to regulate heart rhythms. It is primarily used by cardiologists in patients requiring temporary pacing support.
FDA Clearance Information
Pathway
510K
Number
K800351 ↗
Decision Date
May 28, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on May 28, 1980. Manufactured by Daig, it is classified as a Class 3 device under product code DTB.
What It Is
The pacemaker electrode perm temp is a cardiac device designed to deliver electrical impulses to the heart to maintain an adequate heart rate. It is typically used in temporary pacing situations, where short-term support is needed to stabilize a patient's cardiac rhythm. The device consists of an electrode that is placed in contact with the heart muscle, delivering controlled electrical stimuli.
Clinical Applications
This device is commonly used in emergency and perioperative settings where temporary cardiac pacing is required, such as in cases of bradycardia or heart block. It is often utilized by cardiologists and electrophysiologists in hospital settings, particularly in intensive care units or during cardiac surgeries. The device is suitable for adult patients who require temporary pacing support due to transient conditions affecting heart rhythm.
Indications for Use
The pacemaker electrode perm temp is indicated for patients who need temporary cardiac pacing. This includes individuals experiencing acute heart rhythm disturbances that are expected to resolve or stabilize with short-term intervention.
Practical Considerations
When using this device, clinicians should consider the appropriate electrode size and compatibility with existing pacing systems. Proper placement technique is crucial to ensure effective pacing and minimize complications. The device should be used in settings equipped for cardiac monitoring.
Related Literature
The linked study titled 'Outcomes of primary leadless pacemaker implantation: A systematic review' from 2023 reviews the use of leadless pacemakers as an alternative to traditional pacemakers. It highlights the growing prevalence of leadless devices but notes a lack of consolidated data on their use in emergency situations. Key findings suggest potential benefits in terms of reduced complications, although more research is needed to fully understand their efficacy and safety in acute settings.
Frequently Asked Questions
What is the pacemaker electrode perm temp used for?
It is used for temporary cardiac pacing in patients with heart rhythm disturbances.
What specialties typically use this device?
Cardiologists and electrophysiologists in hospital settings, especially in emergency and perioperative care.
What are the FDA-cleared indications?
It is indicated for temporary pacing in patients with acute heart rhythm issues.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.